Tonsillectomy Using BiZact Tonsilletomy Device

BiZact Versus Electrocautery in Tonsillectomy: A Single-Center Randomized Controlled Trial

The purpose of this study is to describe how Bizact Tonsillectomy Device might affect operative time and intraoperative blood loss in pediatric patients undergoing tonsillectomy, and compare these parameters to the standard technique in tonsillectomy at our institution, which is electrocautery.

Study Overview

• Status: Unknown
• Conditions: Tonsillectomy
• Intervention / Treatment: Device: Bizact tonsillectomy device

Detailed Description

It is a prospective, interventional, single-center study on the performance of Bizact tonsillectomy device on children undergoing tonsillectomy.The required parameters concerning operative time and intra operative blood loss will be obtained during the procedure.There will be no extra clinical visits for the participants.

Operative time will be assessed in 2 ways: 1). By using blade-tipped electrocautery on one tonsil and the BiZact device on the other tonsil for same patient; and 2). using electrocautery for removal of both tonsils and comparing the operative time to an equal number of cases wherein the BiZact device was used for removal of both tonsils.

With regard to intra operative bleeding, it will be quantified into one of 3 groups: 1). No blood in suction tubing, 2). blood in suction tubing but not in the suction canister, and 3). blood in the suction canister.

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 14 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Children scheduled for tonsillectomy at Alberta Children Hospital
2. Tonsillectomy for either recurrent tonsillitis or sleep-disordered breathing.

Exclusion Criteria:

1. Craniofacial abnormalities
2. Bleeding disorders
3. Complex medical background

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bizact device for one tonsil; Bizact tonsillecotmy device which is an advanced bipolar device using radiofrequency and pressure to ligate the encountered vessels during tonsillectomy.	Device: Bizact tonsillectomy device; Bizact tonsillectomy device is an advanced bipolar instrument that uses radiofrequency energy and pressure to ligate vessels interposed between its jaws. The energy produced by the device is automatically adjusted based on tissue impedance in an attempt to minimize thermal tissue damage.
Active Comparator: Electrocautery for second tonsil; Electrocautery is the standard technique used at our institution.	Device: Bizact tonsillectomy device; Bizact tonsillectomy device is an advanced bipolar instrument that uses radiofrequency energy and pressure to ligate vessels interposed between its jaws. The energy produced by the device is automatically adjusted based on tissue impedance in an attempt to minimize thermal tissue damage.
Experimental: Bizact device for both tonsils; Consecutive cases of tonsillectomy will be done using Bizact device and compare the operative time collectively for those cases and compare it to same number of cases done using the standard procedure ( Electrocautery)	Device: Bizact tonsillectomy device; Bizact tonsillectomy device is an advanced bipolar instrument that uses radiofrequency energy and pressure to ligate vessels interposed between its jaws. The energy produced by the device is automatically adjusted based on tissue impedance in an attempt to minimize thermal tissue damage.
Active Comparator: Electrocautery for both tonsils; As explained on the above arm description	Device: Bizact tonsillectomy device; Bizact tonsillectomy device is an advanced bipolar instrument that uses radiofrequency energy and pressure to ligate vessels interposed between its jaws. The energy produced by the device is automatically adjusted based on tissue impedance in an attempt to minimize thermal tissue damage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	The study will be considered success if the mean intra operative time using Bizact device is less than that using electrocautery	during the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative blood loss	The study will be considered success if the mean intraoperative blood loss using Bizact is less than Electrocautery	during the procedure

Collaborators and Investigators

• Sponsor: University of Calgary

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2020
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: March 22, 2020
• First Submitted That Met QC Criteria: March 22, 2020
• First Posted (Actual): March 24, 2020

Study Record Updates

• Last Update Posted (Actual): March 31, 2020
• Last Update Submitted That Met QC Criteria: March 30, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: REB19-0088

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes